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Context: Stroke is a devastating and potentially preventable complication of coronary artery bypass graft (CABG) surgery. Better understanding of the timing and risk factors for stroke associated with CABG are needed.Objectives: To investigate temporal trends in stroke after CABG and to identify stroke risk factors and association with longitudinal outcomes.Design, Setting, and Patients: Prospective study conducted from 1982 through 2009 at a single US academic medical center among 45,432 consecutive patients (mean age, 63 [SD, 10] years) undergoing isolated primary or reoperative CABG surgery. Strokes occurring following CABG were recorded prospectively and classified as having occurred intraoperatively or postoperatively. Complications and survival after stroke were assessed in propensity-matched groups.Intervention: CABG performed using 4 different operative strategies (off-pump, on-pump with beating heart, on-pump with arrested heart, on-pump with hypothermic circulatory arrest).Main Outcome Measures: Hospital complications; late survival.Results: Among 45,432 patients undergoing CABG surgery, 705 (1.6% [95% confidence interval {CI}, 1.4%-1.7%]) experienced a stroke. The prevalence of stroke peaked in 1988 at 2.6% (95% CI, 1.9%-3.4%), then declined at 4.69% (95% CI, 4.68%-4.70%) per year (P = .04), despite increasing patient comorbidity. Overall, 279 strokes (40%) occurred intraoperatively and 409 (58%) occurred postoperatively (timing indeterminate in 17 patients). Postoperative stroke peaked at 40 hours, decreasing to 0.055%/d (95% CI, 0.047%-0.065%) by day 6. Risk factors for both intraoperative and postoperative stroke included older age (odds ratio, 8.5 [95% CI, 3.2-22]) and variables representing arteriosclerotic burden. Intraoperative stroke rates were lowest in off-pump CABG (0.14% [95% CI, 0.029%-0.40%]) and on-pump beating-heart CABG (0% [95% CI, 0%-1.6%]), intermediate with on-pump arrested-heart CABG (0.50% [95% CI, 0.41%-0.61%]), and highest with on-pump CABG with hypothermic circulatory arrest (5.3% [95% CI, 2.0%-11%]). Patients with stroke had worse adjusted hospital outcomes, longer intensive care and postoperative stays, and worse downstream survival (mean, 11 [SD, 8.6] years).Conclusion: Among patients undergoing CABG surgery at a single center over the past 30 years, the occurrence of stroke declined despite an increasing patient risk profile, and more than half of strokes occurred postoperatively rather than intraoperatively. [ABSTRACT FROM AUTHOR]

Objective: The potential risk of inducing ventricular arrhythmias was explored by employing pulsed field ablation (PFA) through the administration of both monophasic and biphasic waveform deliveries., Methods: PFA was applied to specific locations in the right ventricle (RV, n = 5 sites) in swine (n = 2), utilizing identical settings with consistent amplitude, pulse width, and a number of pulses for both monophasic and biphasic waveforms. PFA deliveries were precisely timed in 10-ms intervals across the entire T wave., Results: Using monophasic waveforms, ventricular fibrillation (VF) was induced 7/7 times when PFA pulses were delivered during the T wave. Biphasic waveforms resulted in no ventricular arrhythmias when PFA was delivered across the entire duration of T wave., Conclusions: Our findings indicate that VF can be consistently induced with monophasic pulse waveforms, but not with biphasic pulse waveforms in a porcine model., (© 2024 Medtronic. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Clinical outcomes of catheter ablation for atrial fibrillation (AF) are suboptimal due, in part, to challenges in achieving durable lesions. Although focal point-by-point ablation allows for the creation of any required lesion set, this strategy necessitates the generation of contiguous lesions without gaps. A large-tip catheter, capable of creating wide-footprint ablation lesions, may increase ablation effectiveness and efficiency. In a randomized, single-blind, non-inferiority trial, 420 patients with persistent AF underwent ablation using a large-tip catheter with dual pulsed field and radiofrequency energies versus ablation using a conventional radiofrequency ablation system. The primary composite effectiveness endpoint was evaluated through 1 year and included freedom from acute procedural failure and repeat ablation at any time, plus arrhythmia recurrence, drug initiation or escalation or cardioversion after a 3-month blanking period. The primary safety endpoint was freedom from a composite of serious procedure-related or device-related adverse events. The primary effectiveness endpoint was observed for 73.8% and 65.8% of patients in the investigational and control arms, respectively (P < 0.0001 for non-inferiority). Major procedural or device-related complications occurred in three patients in the investigational arm and in two patients in the control arm (P < 0.0001 for non-inferiority). In a secondary analysis, procedural times were shorter in the investigational arm as compared to the control arm (P < 0.0001). These results demonstrate non-inferior safety and effectiveness of the dual-energy catheter for the treatment of persistent AF. Future large-scale studies are needed to gather real-world evidence on the impact of the focal dual-energy lattice catheter on the broader population of patients with AF. ClinicalTrials.gov identifier: NCT05120193 ., (© 2024. The Author(s).)

Background: The impact of using direct-to-consumer wearable devices as a means to timely detect atrial fibrillation (AF) and to improve clinical outcomes is unknown., Methods: Heartline is a pragmatic, randomized, and decentralized application-based trial of US participants aged ≥65 years. Two randomized cohorts include adults with possession of an iPhone and without a history of AF and those with a diagnosis of AF taking a direct oral anticoagulant (DOAC) for ≥30 days. Participants within each cohort are randomized (3:1) to either a core digital engagement program (CDEP) via iPhone application (Heartline application) and an Apple Watch (Apple Watch Group) or CDEP alone (iPhone-only Group). The Apple Watch Group has the watch irregular rhythm notification (IRN) feature enabled and access to the ECG application on the Apple Watch. If an IRN notification is issued for suspected AF then the study application instructs participants in the Apple Watch Group to seek medical care. All participants were "watch-naïve" at time of enrollment and have an option to either buy or loan an Apple Watch as part of this study. The primary end point is time from randomization to clinical diagnosis of AF, with confirmation by health care claims. Key secondary endpoint are claims-based incidence of a 6-component composite cardiovascular/systemic embolism/mortality event, DOAC medication use and adherence, costs/health resource utilization, and frequency of hospitalizations for bleeding. All study assessments, including patient-reported outcomes, are conducted through the study application. The target study enrollment is approximately 28,000 participants in total; at time of manuscript submission, a total of 26,485 participants have been enrolled into the study., Conclusion: The Heartline Study will assess if an Apple Watch with the IRN and ECG application, along with application-facilitated digital health engagement modules, improves time to AF diagnosis and cardiovascular outcomes in a real-world environment., Trial Registration: ClinicalTrials.gov Identifier: NCT04276441., Competing Interests: Conflict of Interest CMG: Research grant support from Johnson & Johnson and Apple. SS: Research grant from Janssen Pharmaceuticals; Employment with PhysIQ, Inc. DL: Research grant from AtriCure and Biosense Webster. Speakers engagement and advisory boards with Medtronic, Abbott, Boston Scientific, Biosense Webster. MPT: Related to the submitted work: Consulting fees from Johnson & Johnson. Outside of the submitted work: consulting fees from Medtronic Inc, Abbott, Pfizer, Sanofi, InCarda, 100Plus, AliveCor, Acutus, Sanofi, Bristol Myers Squibb, Medtronic; grants from Bristol Myers Squibb, American Heart Association, Sanofi, Apple, Bayer, Gilead, US Food and Drug Administration, employment from iRhythm Technologies. RP: Advisory boards for Johnson & Johnson, Abbott, Medtronic; research support Abbott and American Heart Association. WSJ: Research grants from Bayer, Boehringer Ingelheim, Janssen, Merck, Novartis, National Institute on Aging, Patient-Centered Outcomes Research Institute. TJB: Research grant support from Boehringer Ingelheim, Altathera, Boston Scientific. ABC: Advisory board for Janssen Pharmaceuticals, Medtronic Inc., Abbott, Sanofi Aventis, Milestone Pharmaceuticals, Eagle Pharmaceuticals; honoraria for speaking from Medtronic Inc., Abbott, Sanofi Aventis, Milestone Pharmaceuticals. EP: Research support from Janssen, Bristol-Myers Squibb, Amgen, Esperion; Advisory boards for Novartis, Novo Nordisk, Cerner. JR: Advisory boards for Acesion Pharma and InCarda; consultant for Advanced Medical Education, Element Science, GV, Inc.; steering committee for Janssen; stock options for AblaCor, Element Science, InfoBionic, LuxCath, NewPace, Celero Systems. LS: consultant for Abbott and executive committee member for Johnson & Johnson Heartline trial. MT: Employee of Tiltas Solutions; no other competing interests to disclose. KGT: Full-time employee of Medtronic. NM: Consultant for AtriCure Biosense Webster, Sanofi, Pfizer; honoraria for speaking: Biotronik, Bristol Myers Squibb, Sanofi; research grants from Biosense Webster, St. Jude Medical, Johnson & Johnson, Medtronic, Boston Scientific. MP: Employee of and may hold stock in Apple. AH, SK, JN, SJ, KW, and CVD: employees of Janssen and may hold stock in Johnson & Johnson. JAS: Principal investigator of grants from NIH, Abbott Vascular, and the American College of Cardiology Foundation; consultant to Janssen, Novartis, Amgen, Bristol Myers Squibb, AstraZeneca, Bayer, Terumo, Merck; Scientific Advisory Board of UnitedHealthcare and Board of Directors for Blue Cross and Blue Shield of Kansas City; Copyright owner of the KCCQ, SAQ, and PAQ., (Copyright © 2023 The Authors. Published by Elsevier Inc. All rights reserved.)

Introduction: Contact force has been used to titrate lesion formation for radiofrequency ablation. Pulsed field ablation (PFA) is a field-based ablation technology for which limited evidence on the impact of contact force on lesion size is available., Methods: Porcine hearts (n = 6) were perfused using a modified Langendorff set-up. A prototype focal PFA catheter attached to a force gauge was held perpendicular to the epicardium and lowered until contact was made. Contact force was recorded during each PFA delivery. Matured lesions were cross-sectioned, stained, and the lesion dimensions measured., Results: A total of 82 lesions were evaluated with contact forces between 1.3 and 48.6 g. Mean lesion depth was 4.8 ± 0.9 mm (standard deviation), mean lesion width was 9.1 ± 1.3 mm, and mean lesion volume was 217.0 ± 96.6 mm 3 . Linear regression curves showed an increase of only 0.01 mm in depth (depth = 0.01 × contact force + 4.41, R 2  = 0.05), 0.03 mm in width (width = 0.03 × contact force + 8.26, R 2  = 0.13) for each additional gram of contact force, and 2.20 mm 3 in volume (volume = 2.20 × contact force + 162, R 2  = 0.10)., Conclusion: Increasing contact force using a bipolar, biphasic focal PFA system has minimal effects on acute lesion dimensions in an isolated porcine heart model and achieving tissue contact is more important than the force with which that contact is made., (© 2023 Medtronic Inc and The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Background: Implantable cardioverter defibrillators (ICD) are indicated for primary and secondary prevention of sudden cardiac arrest. Despite enhancements in design and technologies, the ICD lead is the most vulnerable component of the ICD system and failure of ICD leads remains a significant clinical problem. A novel, small-diameter, lumenless, catheter-delivered, defibrillator lead was developed with the aim to improve long-term reliability., Methods and Results: The Lead Evaluation for Defibrillation and Reliability (LEADR) study is a multi-center, single-arm, Bayesian, adaptive design, pre-market interventional pivotal clinical study. Up to 60 study sites from around the world will participate in the study. Patients indicated for a de novo ICD will undergo defibrillation testing at implantation and clinical assessments at baseline, implant, pre-hospital discharge, 3 months, 6 months, and every 6 months thereafter until official study closure. Patients may be participating for a minimum of 18 months to approximately 3 years. Fracture-free survival will be evaluated using a Bayesian statistical method that incorporates both virtual patient data (combination of bench testing to failure with in-vivo use condition data) with clinical patients. The clinical subject sample size will be determined using decision rules for number of subject enrollments and follow-up time based upon the observed number of fractures at certain time points in the study. The adaptive study design will therefore result in a minimum of 500 and a maximum of 900 patients enrolled., Conclusion: The LEADR Clinical Study was designed to efficiently provide evidence for short- and long-term safety and efficacy of a novel lead design using Bayesian methods including a novel virtual patient approach., (© 2022 The Authors. Journal of Cardiovascular Electrophysiology published by Wiley Periodicals LLC.)

Introduction: Catheter ablation for atrial fibrillation (AF) is frequently used for the purpose of rhythm control and improved quality of life (QoL). Although success rates are high, a significant proportion of patients require redo ablation. Data are scarce on patient-centered outcomes and QoL in patients undergoing redo AF ablation. We aimed to assess QoL and clinical outcomes using a large prospectively maintained patient-reported outcomes (PRO) registry., Methods: All patients undergoing redo AF ablation (2013-2016) at our center were enrolled in a prospective registry for outcomes and assessed for QoL using automated PRO surveys (baseline, 3 and 6 months after ablation, every 6 months thereafter). Data were collected over 3 years of follow-up. The atrial fibrillation symptom severity scale (AFSSS) was used as the main measure for QoL. Additional variables included patient-reported improvement, AF burden, and AF-related healthcare utilization including emergency room (ER) visits and hospitalizations., Results: A total of 848 patients were included (28% females, mean age 63.8, 51% persistent AF). By automated PRO, significant improvement in QoL was noted (baseline median AFSSS of 12 [5-18] and ranged between 2 and 4 on subsequent assessments; p < .0001), with ≥70%of patients reported remarkable improvement in their AF-related symptoms. The proportion of patients in AF at the time of baseline survey was 36%, and this decreased to <8% across all time points during follow-up (p < .0001). AF burden was significantly reduced (including frequency and duration of episodes; p < .0001), with an associated decrease in healthcare utilization after 6 months from the time of ablation (including ER visits and hospitalizations; p < .0001). The proportion of patients on anticoagulants or antiarrhythmics decreased on follow-up across all time points (p < .0001 for all variables)., Conclusion: Most patients derive significant QoL benefit from redo AF ablation; with reduction of both AF burden and healthcare utilization., (© 2022 Wiley Periodicals LLC.)

Background: Difficulty of lead extraction does not track well with procedural complications, but several small retrospective studies have lead fibrosis on computed tomography as an important indicator of difficult lead extraction. The purpose of the present study was to apply a standardized gated cardiac computed tomography (CT) protocol to assess fibrosis and study it prospectively to examine the need for powered sheaths and risk outcomes., Methods: We performed a prospective, blinded, multicenter, international study at high-volume lead extraction centers and included patients referred for transvenous lead extraction with at least one lead with a dwell time >1 year and ability to receive a cardiac CT. The degree of fibrosis (as measured by amount of lead adherence to vessel wall) was graded on a scale of 1 to 4 by dedicated CT readers in 3 zones (vein entry to superior vena cava, superior vena cava, and right atrium to lead tip). The primary outcome of the study was number of extractions requiring powered sheaths at zone 2 for each fibrosis group., Results: A total of 200 patients were enrolled in the trial with 196 completing full gated CT and lead extraction analysis. The primary endpoint of powered sheath (laser and mechanical) sheath use was significantly higher in patients with higher fibrosis seen on CT (scores 3+4; 67.8%) at the zone 2 compared to patients with lower fibrosis (scores 1+2; 38.6%; P <0.001). There were 5 major complications with 3 vascular lacerations all occurring in zone 2 in the study., Conclusions: Gated, contrasted CT can predict the need for powered sheaths by identification of fibrosis but did not identify an absolute low-risk cohort who would not need powered sheaths., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT03772704.

Introduction: Pulmonary venous (PV) electrical recovery underlies most arrhythmia recurrences after atrial fibrillation (AF) ablation. Little is known about procedural profiles and outcomes of patients with electrically silent PVs upon redo ablation for AF., Methods: In a prospectively maintained registry, we enrolled 838 consecutive patients (2013-2016) undergoing redo ablation procedures. Ablation procedures targeted the PVs, the PV antra, and non-PV sites at operators' discretion. Procedural profiles and clinical outcomes were assessed. The primary outcome was freedom from AF after a 3-month blanking period. The secondary outcome was improvement in quality of life., Results: Most patients undergoing redo AF ablation (n = 684, 82%) had PV reconnection while the remaining 154 (18%) had electrically silent PVs. Patients with recurrent AF and electrically silent PVs were older (66 vs. 64 years, p = .02), had more prior ablation procedures (median 2 IQR 1-3 vs 1 IQR 1-2 p = .001), were more likely to have non-paroxysmal AF (62% vs. 49%, p = .004) and atrial flutter (48% vs. 29%, p = .001) and had significantly larger left atrial volumes (89 vs. 81 ml, p = .003). Patients with silent PVs underwent a more extensive non-PV ablation strategies with antral extension of prior ablation sets in addition to ablation of the roof, appendage, inferior to the right PVs, peri-mitral flutter lines, cavotricuspid isthmus lines and ablation in the coronary sinus. Upon one year of follow-up, patients with electrically silent PVs were less likely to remain free from recurrent atrial arrhythmias (64% vs. 76%, p = .008). Regardless of PV reconnection status, redo ablation resulted in improvement in quality of life., Conclusion: Rhythm control with extensive ablation allowed maintenance of sinus rhythm in about two thirds of patients with silent PVs during redo AF ablation procedures. Regardless of PV reconnection status, redo ablation resulted in improvement in quality of life. This remains a challenging group of patients, highlighting the need to better understand non-PV mediated AF., (© 2022 Wiley Periodicals LLC.)

Background: Implant site hematoma is a known complication of cardiac device procedures and can lead to major consequences., Objectives: To evaluate risk factors for hematoma and further understand the relationship between anticoagulant (AC), antiplatelet (AP) use, and hematoma development., Methods: We included 6800 patients from the WRAP-IT trial. To assess baseline and procedural characteristics associated with hematoma within the first 30 days postprocedure, a stepwise Cox regression model was implemented with minimal Akaike information criterion. Cox regressions were also used to evaluate AC/AP use and hematoma risk., Results: The overall rate of hematoma was 2.2%. The model identified 11 baseline and procedural characteristics associated with hematoma risk. AC use (hazard ratio [HR]: 2.44, P < .001), lower body mass index (HR: 1.06, P < .001), and history of valve surgery (HR: 2.11, P < .001) were associated with the highest risk. AP use, male sex, history of coronary artery disease, existing pocket, history of nonischemic cardiomyopathy, number of previous cardiac implantable electronic device (CIED) procedures, procedure time, and lead revision were associated with moderate risk. Antithrombotic use was high overall (86%) and AC+AP use was highly predictive of hematoma risk. Regardless of AC status, AP use was associated with an almost doubling of risk vs no AP (HR = 1.85, P = .0006) in the general cohort. Interruption of AC was associated with the lowest hematoma risk (HR = 2.35) while heparin bridging (HR = 4.98) and AP use vs no AP use (HR = 1.85) was associated with the highest hematoma risk., Conclusion: The results of this analysis highlight risk factors associated with the development of hematoma in patients undergoing CIED procedures and can inform antithrombotic management., (© 2022 Heart Rhythm Society. Published by Elsevier Inc.)

Objectives: This study sought to examine the effect of the return electrode's surface area on bipolar RFA lesion size., Background: Bipolar radiofrequency ablation (RFA) is typically performed between 2 3.5-mm tip catheters serving as active and return electrodes. We hypothesized that increasing the surface area of the return electrode would increase lesion dimensions by reducing the circuit impedance, thus increasing the current into a larger tissue volume enclosed between the electrodes., Methods: In step 1, ex vivo bipolar RFA was performed between 3.5-mm and custom-made return electrodes with increasing surface areas (20, 80, 180 mm 2 ). In step 2, ex vivo bipolar RFA was performed between 3.5-mm and 3.5-mm or 8-mm electrode catheters positioned perpendicular or parallel to the tissue. In step 3, in vivo bipolar RFA was performed between 3.5-mm and either 3.5-mm or 8-mm parallel electrode at the: 1) left ventricular summit; 2) interventricular septum; and 3) healed anterior infarction., Results: In step 1, increasing the surface area of the return electrode resulted in lower circuit impedance (R = -0.65; P < 0.001), higher current (R = +0.80; P < 0.001), and larger lesion volume (R = +0.88; P < 0.001). In step 2, an 8-mm return electrode parallel to tissue produced larger and deeper lesions compared with a 3.5-mm return electrode (P = 0.014 and P = 0.02). Similarly, in step 3, compared with a 3.5-mm, bipolar RFA with an 8-mm return electrode produced larger (volume: 1,525 ± 871 mm 3 vs 306 ± 310 mm 3 , respectively; P < 0.001) and more transmural lesions (88% vs 0%; P < 0.001)., Conclusions: Bipolar RFA using an 8-mm return electrode positioned parallel to the tissue produces larger lesions in comparison with a 3.5-mm return electrode., Competing Interests: Funding Support and Author Disclosures Mr Bubar is an employee of Biosense Webster. Dr Tarakji receives consultation fees from AliveCor, Medtronic, Janssen, and Pfizer. Dr Anter has received research grants and speaking honoraria from Biosense Webster, Boston Scientific, Affera Inc, and Itamar Medical; and holds stock options in Affera Inc. Dr Koruth has received research grants from Affera Inc, Farapulse, Cardiofocus, Biosense, Acutus, Kardium; has equity in Affera Inc; and serves as a consultant to Farapulse and Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

New-onset left bundle branch block (LBBB) is common after transcatheter aortic valve implantation (TAVI) but can resolve in the post-TAVI period. We sought to examine the incidence, predictors, and outcomes of early resolution of new-onset LBBB among TAVI recipients with a SAPIEN 3 (S3) valve. Among 1,203 S3-TAVI recipients without a pre-existing pacemaker or wide QRS complex at our institution between 2016 and 2019, we identified 143 patients who developed new-onset LBBB during TAVI and divided them according to the resolution or persistence of LBBB by the next day post-TAVI to compare high-degree atrioventricular block (HAVB) and permanent pacemaker (PPM) rates. Patients with resolved LBBB (n = 74, 52%), compared with those with persistent LBBB, were more often women and had a shorter QRS duration at baseline and post-TAVI, with a smaller S3 size and a shallower implantation depth. A multivariable logistic regression model demonstrated significant associations of post-TAVI QRS duration (per 10 ms increase, odds ratio = 0.60 [95% confidence interval = 0.44 to 0.82]) and implantation depth (per 1-mm-depth-increase, 0.77 [0.61 to 0.97]) with a lower likelihood of LBBB resolution. No patient with resolved LBBB developed HAVB within 30 days post-TAVI. Meanwhile, 8 patients (11.6%) with persistent LBBB developed HAVB. The 2-year PPM rate was significantly higher after persistent LBBB than after resolved LBBB (30.3% vs 4.5%, log-rank p <0.001), mainly driven by higher 30-day PPM rate (18.8% vs 0.0%). In conclusion, about half of new-onset LBBBs that occurred during S3-TAVI resolved by the next day post-TAVI without HAVB. In contrast, new-onset persistent LBBB may need follow-up with ambulatory monitoring within 30 days because of the HAVB risk., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background: In the absence of randomized data, an expert panel recently proposed an algorithm for conduction disturbance management in transcatheter aortic valve implantation (TAVI) recipients. However, external validations of its recommendations are limited., Methods: We retrospectively identified 808 patients without a pre-existing pacing device who underwent transfemoral TAVI with the Sapien 3 valve at our institution in 2018-2019. Patients were grouped based on pre-existing conduction disturbance and immediate post-TAVI electrocardiogram. Timing of temporary pacemaker (TPM) removal and hospital discharge were compared with those of the expert panel recommendations to evaluate the associated risk of TPM reinsertion and permanent pacemaker (PPM) implantation., Results: In most group 1 patients (no electrocardiogram changes without pre-existing right bundle branch block), the timing of TPM removal and discharge were concordant with those of the expert panel recommendations, with low TPM reinsertion (0.8%) and postdischarge PPM (0.8%) rates. In the majority of group 5 patients (procedural high-degree/complete atrioventricular block), TPM was maintained, followed by PPM implantation, compatible with the expert panel recommendations. In contrast, in groups 2-4 (pre-existing/new conduction disturbances), earlier TPM removal than recommended by the expert panel (mostly, immediately after procedure) was feasible in 97.5%-100% of patients, with a low TPM reinsertion rate (0.0%-1.8%); earlier discharge was also feasible in 50.0%-65.5%, with a low 30-day postdischarge PPM rate (0.0%-2.8%) and no 30-day death., Conclusions: Early TPM removal and discharge after TAVI appear safe and feasible in the majority of cases. These data may provide a framework for an early, streamlined hospital discharge plan for TAVI recipients, optimizing both cost savings and patient safety., Competing Interests: The authors declare no conflict of interest., (© 2022 The Authors.)

Aims: The 2021 European Society of Cardiology guidelines recommend early pacemaker implantation in pre-existing right bundle branch block (RBBB) patients who develop PR prolongation or QRS axis change after transcatheter aortic valve implantation (TAVI). We aimed to evaluate this recommendation in TAVI recipients with a balloon-expandable valve (BEV)., Methods and Results: We retrospectively reviewed 188 pre-existing RBBB patients without pre-existing permanent pacemaker (PPM) who underwent TAVI with a BEV at our institution in 2015-19. Patients who developed high-degree atrioventricular block (HAVB) during TAVI or within 24 h post-TAVI were excluded. Eligible patients were divided according to the guideline-directed criteria (ΔPR interval ≥20 ms and/or QRS axis change). Patients who met the criteria ( n = 102, 54.3%), compared with those who did not ( n = 86), had a higher prevalence of baseline right axis deviation and were more likely to have received a larger valve with greater oversizing. The 30-day delayed HAVB rate did not differ significantly between the groups (3.9% vs. 4.7%, P = 1.00; odds ratio = 0.84, 95% confidence interval = 0.20-3.45). There was also no significant difference in terms of death (5.0% vs. 8.4% at 1 year; overall log-rank P = 0.94) or a composite of death or PPM implantation (14.8% vs. 16.6% at 1 year; overall log-rank P = 0.94) during follow-up post-TAVI. The majority of PR prolongations (79.4%) and QRS axis changes (52.0%) regressed within the following 24 h., Conclusion: The present data did not demonstrate an association of significant changes in PR interval or QRS axis with heightened delayed HAVB risk in BEV recipients with pre-existing RBBB. Prospective studies are warranted to confirm these findings., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: Implantable cardioverter-defibrillator (ICD) lead monitoring diagnostic alerts facilitate the diagnosis of structural lead failure., Objective: The purpose of this study was to prospectively study the performance of Medtronic ICD lead monitoring alerts., Methods: A prespecified ancillary substudy, World-Wide Randomized Antibiotic Envelope Infection Prevention Trial, was conducted in patients with an ICD with all available alerts enabled. The investigators reported possible lead system events (LSEs), with or without an alert. An independent committee reviewed all data and classified events as lead failure, other LSE, or nonlead system events (NLEs)., Results: In 4942 patients who were followed for 19.4 ± 8.7 months, there were 124 alerts (65 LSEs, 59 NLEs) and 19 LSEs without an alert. Lead monitoring alerts had 100% sensitivity for the 48 adjudicated lead failures (95% confidence interval 92.6%-100%) and for 10 events adjudicated as either lead failure or connection issue. The positive predictive value of alerts for lead failure was 38.7% (48 of 124). For 34 pace-sense lead failures, an alert that incorporated oversensing was more sensitive than the pacing impedance threshold alert (33 patients [97.1%] vs 9 patients [26.5%]; P < .0001). However, the sensitivity was only 13.6% for lead dislodgments or perforations. Inappropriate shocks occurred in 2 patients with pace-sense lead failure (5.9%). No patient had unnecessary lead replacement for any of the NLEs., Conclusion: In this first real-world prospective study, lead monitoring alerts had 100% sensitivity for identifying lead failures. Although their positive predictive value was modest, no false-positive alerts resulted in an unnecessary lead replacement. For the diagnosis of pace-sense lead failure, an alert for oversensing was more sensitive than a pacing impedance threshold alert., Trial Registration: ClinicalTrials.gov identifier: NCT02277990., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Bradyarrhythmias leading to permanent pacemaker (PPM) implantation continue to be a complication after transcatheter aortic valve replacement (TAVR)., Objective: The purpose of this study was to assess the prevalence of bradyarrhythmias using an electrocardiographic (ECG) extended rhythm recording in patients pre- and post-TAVR and whether they can predict the need for PPM., Methods: This was a prospective single-center study in patients undergoing TAVR. Patients received an ECG patch for 2 weeks pre-, immediately post-, and 2-3 months post-TAVR. Caring physicians were blinded to the results of the patch except when predefined urgent arrhythmias were detected. The main outcome was the need for PPM implantation after TAVR., Results: We enrolled 110 patients, of whom 96 underwent TAVR and were included in the final analysis. Bradyarrhythmias, defined as a pause of 3 seconds or more, occurred in 5.2%, 12.7%, and 7% of patients pre-, immediately post-, and 2-3 months post-TAVR, respectively. PPM implantation occurred in 12 patients (12.5%), of whom 9 (9.4%) underwent implantation during their index hospitalization while 3 (3.1%) required implantation postdischarge for indications other than heart block. No patients required PPM after receiving an ECG patch 2-3 months post-TAVR. Significant baseline predictors for the need for PPM included the presence of right bundle branch block and increased QRS duration. Bradyarrhythmias detected by the ECG patch did not predict the need for PPM at either the index hospitalization or the follow-up period., Conclusion: Bradyarrhythmias are common and can be detected with extended ECG monitoring before and after TAVR; however, in our study they did not predict the need for PPM after TAVR (ClinicalTrials.gov identifier: NCT03180073)., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Introduction: Chemotherapy-induced cardiomyopathy has been increasingly recognised as patients are living longer with more effective treatments for their malignancies. Anthracyclines are known to cause left ventricular (LV) dysfunction. While heart failure medications are frequently used, some patients may need consideration for device-based therapies such as cardiac resynchronisation therapy (CRT). However, the role of CRT in anthracycline-induced cardiomyopathy (AIC) is not well understood., Methods: We performed a retrospective review of all patients undergoing CRT implantation at our centre from 2003 to 2019 with a diagnosis of AIC. The LV remodelling and survival outcomes of this population were obtained and then compared with consecutive patients with other aetiologies of non-ischaemic cardiomyopathy (NICM)., Results: A total of 34 patients underwent CRT implantation with a diagnosis of AIC with a mean age of 60.5±12.7 years, left ventricular ejection fraction (LVEF) of 21.7%±7.4%, and 11.3±7.5 years and 10.2±7.4 years from cancer diagnosis and last anthracycline exposure, respectively. At 9.6±8.1 months after CRT implantation, there was an increase of LVEF from 21.8%±7.6% to 30.4%±13.0% (p<0.001). Patients whose LVEF increased by at least 10% post-CRT implant (42.5% of cohort) survived significantly longer than patients who failed to improve their LVEF by that amount (p=0.01). A propensity matched analysis between patients with AIC and 369 consecutive patients with other aetiologies of NICM who underwent CRT implantation during the same period revealed no significant differences in improvement in LVEF or long-term survival., Conclusions: Patients with AIC undergo LV remodelling with CRT at rates similar to other aetiologies of NICM. Furthermore, AIC post-CRT responders have a favourable long-term mortality compared with non-responders., Competing Interests: Competing interests: TC: consultant, Biotronik. KGT: consulting and honoraria from Medtronic and Spectranetics Corporation; advisory board, Medtronic and AliveCor. DC: consultant, Abbott and Boston Scientific. OW: Honoraria Spectranetics. NV: consultant/honoraria from St. Jude Medical, Boston Scientific, Biotronik and Medtronic. BLW: honoraria/consultant fees from Abbott, Medtronic and Philipps. JR: honoraria/consultant fees from Abbott and Medtronic. All other authors have no disclosures to report., (© Author(s) (or their employer(s)) 2022. No commercial re-use. See rights and permissions. Published by BMJ.)

Objectives: This study aimed to identify risk factors for infection after secondary cardiac implantable electronic device (CIED) procedures., Background: Risk factors for CIED infection are not well defined and techniques to minimize infection lack supportive evidence. WRAP-IT (World-wide Randomized Antibiotic Envelope Infection Prevention trial), a large study that assessed the safety and efficacy of an antibacterial envelope for CIED infection reduction, offers insight into procedural details and infection prevention strategies., Methods: This analysis included 2,803 control patients from the WRAP-IT trial who received standard preoperative antibiotics but not the envelope (44 patients with major infections through all follow-up). A multivariate least absolute shrinkage and selection operator machine learning model, controlling for patient characteristics and procedural variables, was used for risk factor selection and identification. Risk factors consistently retaining predictive value in the model (appeared >10 times) across 100 iterations of imputed data were deemed significant., Results: Of the 81 variables screened, 17 were identified as risk factors with 6 being patient/device-related (nonmodifiable) and 11 begin procedure-related (potentially modifiable). Patient/device-related factors included higher number of previous CIED procedures, history of atrial arrhythmia, geography (outside North America and Europe), device type, and lower body mass index. Procedural factors associated with increased risk included longer procedure time, implant location (non-left pectoral subcutaneous), perioperative glycopeptide antibiotic versus nonglycopeptide, anticoagulant, and/or antiplatelet use, and capsulectomy. Factors associated with decreased risk of infection included chlorhexidine skin preparation and antibiotic pocket wash., Conclusions: In WRAP-IT patients, we observed that several procedural risk factors correlated with infection risk. These results can help guide infection prevention strategies to minimize infections associated with secondary CIED procedures., Competing Interests: Funding Support and Author Disclosures Supported by Medtronic, Inc. Dr Tarakiji has received honoraria/consultant fees from AliveCor and Medtronic outside the submitted work. Dr Krahn has received honoraria/consultant fees from Medtronic outside the submitted work. Dr Poole has received honoraria/consultant fees from Boston Scientific, EBR Solutions, Kestra, and Medtronic outside the submitted work. Dr Mittal has received honoraria/consultant fees from Abbott, Boston Scientific, and Medtronic outside the submitted work. Dr Kennergren has received honoraria/consultant fees from Biotronik, Boston Scientific, Medtronic, and Philips outside the submitted work. Dr Biffi has received honoraria/consultant fees from Boston Scientific, Biotronik, and Medtronic outside the submitted work. Drs Korantzopoulos and Dallaglio have received honoraria/consultant fees from Medtronic outside the submitted work. Drs Lexcen and Lande and Mrs Hilleren and Holbrook have received personal fees from Medtronic. Dr Wilkoff has received honoraria/consultant fees from Abbott, Medtronic, and Philips outside the submitted work., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: Hematoma is a complication of cardiac implantable electronic device (CIED) procedures and may lead to device infection. The TYRX antibacterial envelope reduced major CIED infection by 40% in the randomized WRAP-IT (World-wide Randomized Antibiotic Envelope Infection Prevention Trial) study, but its effectiveness in the presence of hematoma is not well understood., Objective: The purpose of this study was to evaluate the incidence and infectious consequences of hematoma and the association between envelope use, hematomas, and major CIED infection among WRAP-IT patients., Methods: All 6800 study patients were included in this analysis (control 3429; envelope 3371). Hematomas occurring within 30 days postprocedure (acute) were characterized and grouped by study treatment and evaluated for subsequent infection risk. Data were analyzed using Cox proportional hazard regression modeling., Results: Acute hematoma incidence was 2.2% at 30 days, with no significant difference between treatment groups (envelope vs control hazard ratio [HR] 1.15; 95% confidence interval [CI] 0.84-1.58; P = .39). Through all follow-up, the risk of major infection was significantly higher among control patients with hematoma vs those without (13.1% vs 1.6%; HR 11.3; 95% CI 5.5-23.2; P <.001). The risk of major infection was significantly lower in the envelope vs control patients with hematoma (2.5% vs 13.1%; HR 0.18; 95% CI 0.04-0.85; P = .03)., Conclusion: The risk of hematoma was 2.2% among WRAP-IT patients. Among control patients, hematoma carried a >11-fold risk of developing a major CIED infection. This risk was significantly mitigated with antibacterial envelope use, with an 82% reduction in major CIED infection among envelope patients who developed hematoma compared to control., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: High-power short-duration (HP-SD) radiofrequency ablation (RFA) has been proposed as a method for producing rapid and effective lesions for pulmonary vein isolation. The underlying hypothesis assumes an increased resistive heating phase and decreased conductive heating phase, potentially reducing the risk for esophageal thermal injury. The objective of this study was to compare the esophageal temperature dynamic profile between HP-SD and moderate-power moderate-duration (MP-MD) RFA ablation strategies., Methods: In patients undergoing pulmonary vein isolation, RFA juxtaposed to the esophagus was delivered in an alternate sequence of HP-SD (50 W, 8-10 s) and MP-MD (25 W, 15-20 s) between adjacent applications (distance, ≤4 mm). Esophageal temperature was recorded using a multisensor probe (CIRCA S-CATH). Temperature data included magnitude of temperature rise, maximal temperature, time to maximal temperature, and time return to baseline. In swine, a similar experimental design compared the effect of HP-SD and MP-MD on patterns of esophageal injury., Results: In 20 patients (68.9±5.8 years old; 60% persistent atrial fibrillation), 55 paired HP-SD and MP-MD applications were analyzed. The esophageal temperature dynamic profile was similar between HP-SD and MP-MD ablation strategies. Specifically, the magnitude of temperature rise (2.1 °C [1.4-3] versus 2.0 °C [1.5-3]; P =0.22), maximal temperature (38.4 °C [37.8-39.3] versus 38.5 °C [37.9-39.4]; P =0.17), time to maximal temperature (24.9±7.5 versus 26.3±6.8 s; P =0.1), and time of temperature to return to baseline (110±23.2 versus 111±25.1 s; P =0.86) were similar between HP-SD and MP-MD ablation strategies. In 6 swine, esophageal injury was qualitatively similar between HP-SD and MP-MD strategies., Conclusions: Esophageal temperature dynamics are similar between HP-SD and MP-MD RFA strategies and result in comparable esophageal tissue injury. Therefore, when using a HP-SD RFA strategy, the shorter application duration should not prompt shorter intervals between applications.

Aim: The Prevention of Arrhythmia Device Infection Trial (PADIT) infection risk score, developed based on a large prospectively collected data set, identified five independent predictors of cardiac implantable electronic device (CIED) infection. We performed an independent validation of the risk score in a data set extracted from U.S. healthcare claims., Methods and Results: Retrospective identification of index CIED procedures among patients aged ≥18 years with at least one record of a CIED procedure between January 2011 and September 2014 in a U.S health claims database. PADIT risk factors and major CIED infections (with system removal, invasive procedure without system removal, or infection-attributable death) were identified through diagnosis and procedure codes. The data set was randomized by PADIT score into Data Set A (60%) and Data Set B (40%). A frailty model allowing multiple procedures per patient was fit using Data Set A, with PADIT score as the only predictor, excluding patients with prior CIED infection. A data set of 54 042 index procedures among 51 623 patients with 574 infections was extracted. Among patients with no history of prior CIED infection, a 1 unit increase in the PADIT score was associated with a relative 28% increase in infection risk. Prior CIED infection was associated with significant incremental predictive value (HR 5.66, P < 0.0001) after adjusting for PADIT score. A Harrell's C-statistic for the PADIT score and history of prior CIED infection was 0.76., Conclusion: The PADIT risk score predicts increased CIED infection risk, identifying higher risk patients that could potentially benefit from targeted interventions to reduce the risk of CIED infection. Prior CIED infection confers incremental predictive value to the PADIT score., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background: High adherence to remote monitoring (RM) in pacemaker (PM) patients improves outcomes; however, adherence remains suboptimal. Bluetooth low-energy (BLE) technology in newer-generation PMs enables communication directly with patient-owned smart devices using an app without a bedside console., Objective: To evaluate the success rate of scheduled RM transmissions using the app compared to other RM methods., Methods: The BlueSync Field Evaluation was a prospective, international cohort evaluation, measuring the success rate of scheduled RM transmissions using a BLE PM or cardiac resynchronization therapy PM coupled with the MyCareLink Heart app. App transmission success was compared to 3 historical "control" groups from the Medtronic de-identified CareLink database: (1) PM patients with manual communication using a wand with a bedside console (PM manual transmission), (2) PM patients with wireless automatic communication with the bedside console (PM wireless); (3) defibrillator patients with similar automatic communication (defibrillator wireless)., Results: Among 245 patients enrolled (age 64.8±15.6 years, 58.4% men), 953 transmissions were scheduled through 12 months, of which 902 (94.6%) were successfully completed. In comparison, transmission success rates were 56.3% for PM manual transmission patients, 77.0% for PM wireless patients, and 87.1% for defibrillator wireless patients. Transmission success with the app was superior across matched cohorts based on age, sex, and device type (single vs dual vs triple chamber)., Conclusion: The success rate of scheduled RM transmissions was higher among patients using the smart device app compared to patients using traditional RM using bedside consoles. This novel technology may improve patient engagement and adherence to RM., (© 2021 Heart Rhythm Society. Published by Elsevier Inc.)

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Technological innovations reach deeply into our daily lives and an emerging trend supports the use of commercial smart wearable devices to manage health. In the era of remote, decentralized and increasingly personalized patient care, catalysed by the COVID-19 pandemic, the cardiovascular community must familiarize itself with the wearable technologies on the market and their wide range of clinical applications. In this Review, we highlight the basic engineering principles of common wearable sensors and where they can be error-prone. We also examine the role of these devices in the remote screening and diagnosis of common cardiovascular diseases, such as arrhythmias, and in the management of patients with established cardiovascular conditions, for example, heart failure. To date, challenges such as device accuracy, clinical validity, a lack of standardized regulatory policies and concerns for patient privacy are still hindering the widespread adoption of smart wearable technologies in clinical practice. We present several recommendations to navigate these challenges and propose a simple and practical 'ABCD' guide for clinicians, personalized to their specific practice needs, to accelerate the integration of these devices into the clinical workflow for optimal patient care., (© 2021. Springer Nature Limited.)

This collaborative statement from the Digital Health Committee of the Heart Rhythm Society provides everyday clinical scenarios in which wearables may be utilized by patients for cardiovascular health and arrhythmia management. We describe herein the spectrum of wearables that are commercially available for patients, and their benefits, shortcomings and areas for technological improvement. Although wearables for rhythm diagnosis and management have not been examined in large randomized clinical trials, undoubtedly the usage of wearables has quickly escalated in clinical practice. This document is the first of a planned series in which we will update information on wearables as they are revised and released to consumers., (© 2021 Published by Elsevier Inc. on behalf of Heart Rhythm Society.)

Background: Activation maps of scar-related atrial tachycardias (AT) can be challenging to interpret due to difficulty in inaccurate annotation of electrograms, and an arbitrarily predefined mapping window. A novel mapping software integrating vector data and applying an algorithmic solution taking into consideration global activation pattern has been recently described (Coherent™, Biosense Webster "Investigational")., Objective: We aimed to assess the investigational algorithm to determine the mechanism of AT compared with the standard algorithm., Methods: This study included patients who underwent ablation of scar-related AT using the Carto 3 and the standard activation algorithm. The mapping data were analyzed retrospectively using the investigational algorithm, and the mechanisms were evaluated by two independent electrophysiologists., Results: A total of 77 scar-related AT activation maps were analyzed (89.6% left atrium, median tachycardia cycle length of 273 ms). Of those, 67 cases with a confirmed mechanism of arrhythmia were used to compare the activation software. The actual mechanism of the arrhythmia was more likely to be identified with the investigational algorithm (67.2% vs. 44.8%, p = .009). In five patients with dual-loop circuits, 3/5 (60%) were correctly identified by the investigational algorithm compared to 0/5 (0%) with the standard software. The reduced atrial voltage was prone to lead to less capable identification of mechanism (p for trend: .05). The investigational algorithm showed higher inter-reviewer agreement (Cohen's kappa .62 vs. .47)., Conclusions: In patients with scar-related ATs, activation mapping algorithms integrating vector data and "best-fit" propagation solution may help in identifying the mechanism and the successful site of termination., (© 2021 Wiley Periodicals LLC.)

Background: Cardiac device procedures require tissue dissection to free existing device lead(s). Common techniques include blunt dissection, standard electrocautery, and low-temperature electrocautery (PlasmaBlade, Medtronic); however, data on the type of electrosurgical tool used and the development of procedure- or lead-related adverse events are limited., Objective: The purpose of this study was to determine whether standard or low-temperature electrocautery impacts the development of an adverse event., Methods: We evaluated patients enrolled in WRAP-IT (Worldwide Randomized Antibiotic EnveloPe Infection PrevenTion Trial) undergoing cardiac implantable electronic device (CIED) revision, upgrade, or replacement. All adverse events were adjudicated by an independent physician committee. Data were analyzed using Cox proportional hazard regression modeling., Results: In total, 5641 patients underwent device revision/upgrade/replacement. Electrocautery was used in 5205 patients (92.3%) (mean age 70.6 ± 12.7 years; 28.8% female), and low-temperature electrocautery was used in 1866 patients (35.9%). Compared to standard electrocautery, low-temperature electrocautery was associated with a 23% reduction in the incidence of a procedure- or lead-related adverse event through 3 years of follow up (hazard ratio [HR] 0.77; 95% confidence interval [CI] 0.65-0.91; P = .002). After controlling for the number of active leads, degree of capsulectomy, degree of lead dissection, and renal dysfunction, low-temperature electrocautery was associated with a 32% lower risk of lead-related adverse events (HR 0.68; 95% CI 0.52-0.89; P = .004). These effects were consistent across a spectrum of lead-related adverse event types., Conclusion: This study represents one of the largest assessments of electrocautery use in patients undergoing CIED revision, upgrade, or replacement procedures. Compared to standard electrocautery, low-temperature electrocautery significantly reduces adverse effects from these procedures., (Copyright © 2021 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Objectives: To model the cost-effectiveness of the TYRX Absorbable Antibacterial Envelope when used in patients at increased risk of cardiac implantable electronic device (CIED) infection in the context of 3 European healthcare systems: Germany, Italy, and England., Methods: A decision tree model with a lifetime horizon was populated using data from the Worldwide Randomized Antibiotic Envelope Infection Prevention Trial, a large multicenter randomized controlled trial. Use of the antibacterial envelope adjunctive to standard of care was compared to standard of care infection prevention alone. Patients in the model were divided into subgroups based on presence of factors known to increase infection risk., Results: The antibacterial envelope had the most favorable cost-effectiveness profile when patients had previously experienced CIED infection, had a history of immunosuppressive therapy, or had a Prevention of Arrhythmia Device Infection Trial (PADIT) score indicating high risk of infection (scores ≥6) at cost-effectiveness thresholds of €50 000 in Germany (assumed in the absence of an official threshold), €40 000 in Italy, and £30 000 in England. Probabilistic sensitivity analysis indicated that the antibacterial envelope was likely to be cost-effective in patients with other risk factors (including replacement of high power CIEDs, generator replacement with lead modification, and PADIT scores indicating intermediate risk of infection) when used with some device types and in some countries., Conclusions: The absorbable antibacterial envelope was associated with cost-effectiveness ratios below European benchmarks in selected patients at increased risk of infection, suggesting the envelope provides value for European healthcare systems by reducing CIED infections., (Copyright © 2021 ISPOR–The Professional Society for Health Economics and Outcomes Research. Published by Elsevier Inc. All rights reserved.)

The occurrence of cardiac implantable electronic devices (CIED) infections and related adverse outcomes have an important financial impact on the healthcare system, with hospitalization length of stay (2-3 weeks on average) being the largest cost driver, including the cost of device system extraction and device replacement accounting for more than half of total costs. In the recent literature, the economic profile of the TYRX™ absorbable antibacterial envelope was analysed taking into account both randomized and non-randomized trial data. Economic analysis found that the envelope is associated with cost-effectiveness ratios below USA and European benchmarks in selected patients at increased risk of infection. Therefore, the TYRX™ envelope, by effectively reducing CIED infections, provides value according to the criteria of affordability currently adopted by USA and European healthcare systems., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Cardiovascular implantable electronic devices (CIED) are effective and important components of modern cardiovascular care. Despite the dramatic improvements in the functionality and reliability of these devices, over time patients are at risk for developing several morbidities, the most feared of which are local and systemic infections. Despite significant financial investment and aggressive therapy with hospitalization, intravenous antibiotics, and transvenous lead extraction, the outcomes include a 1-year mortality rate as high as 25%. This risk of infection has increased over time, likely due to the increased complexity of the surgical interventions required to insert and replace these devices. The only way to reduce this morbidity and mortality is to prevent these infections, and other than preoperative antibiotics, there were little data supporting effective therapy until the WRAP-IT trial provided randomized data showing that pocket infections can be reduced by 60% at 12 months and major CIED infections reduced by 40% at 1 year with the use of the absorbable antibiotic eluting envelope in patient CIED procedures at high risk of infection. Not all CIED procedures are at high risk of infection and justify the use of the envelope, but cost-effectiveness data support the use of the antibiotic envelope particularly in patients with defibrillator replacements, revisions, and upgrades, such as to a resynchronization device and in patients with prior CIED infection, history of immunocompromise, two or more prior procedures, or a history of renal dysfunction., (© The Author(s) 2021. Published by Oxford University Press on behalf of the European Society of Cardiology.)

[Figure: see text].

Background: Infectious endocarditis is often complicated by conduction abnormalities at the time of presentation. Cardiac surgery is the treatment of choice for many infectious endocarditis patients, but carries an additional risk of persistent postoperative conduction abnormality. We sought to define the incidence and clinical predictors of significant postoperative conduction abnormalities necessitating permanent pacemaker implantation after cardiac surgery for infectious endocarditis., Methods: All consecutive patients with infectious endocarditis who were surgically treated at Cleveland Clinic from 2007 to 2013 were identified using the Cleveland Clinic Infective Endocarditis Registry and the Cardiovascular Information Registry. Patients with a pre-existing cardiac implantable electronic device were excluded. The primary outcome was the need for permanent pacemaker placement postoperatively for atrioventricular block. Regression analysis was performed to identify risk factors for permanent pacemaker requirement., Results: Among 444 infectious endocarditis patients who underwent cardiac surgery for infectious endocarditis, 57 (13%) required postoperative permanent pacemaker for atrioventricular block. Multivariable analysis identified that prolongation in preoperative PR and QRS intervals, Staphylococcus aureus as the infectious endocarditis organism, the presence of intracardiac abscess, tricuspid valve involvement, and prior valvular surgery independently predicted postoperative permanent pacemaker placement. The developed model exhibited excellent predictive ability (c-statistic 0.88) and calibration., Conclusion: Infectious endocarditis cardiac surgery patients often require a postoperative permanent pacemaker. Preoperative conduction abnormality, S. aureus infection, abscess, tricuspid valve involvement, and prior valvular surgery are strong predictors of postoperative permanent pacemaker placement., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Background: Direct-to-consumer devices allow patients to record electrocardiograms (ECG) and detect atrial fibrillation (AF). Clinical adoption of these devices has been limited owing to the lack of efficient workflow., Objective: To assess a new care model for following patients after AF ablation that uses a smartphone ECG coupled with a novel cloud-based platform., Methods: This was a pilot study to describe AF detection, healthcare utilization, use of additional ECGs and cardiac monitors, and changes in anxiety after AF ablation. Patients presenting 3-4 months after early successful AF ablation were randomized into a control group with standard clinical follow-up or a self-monitoring group using smartphone ECG (Kardia Mobile, KM) coupled with a cloud-based platform (KardiaPro, KP) that alerted the physician when AF was detected and followed for 6 months., Results: A total of 100 patients were randomized: 51 to the KM/KP group and 48 to the control group (1 withdrew). AF was detected in 18 patients (18.2%), 11 (21.6%) in the KM/KP group and 7 (14.6%) in the control group ( P = .42). AF detection occurred at a median of 68 and 91 days in the KM/KP and control groups, respectively ( P = .93). These differences were not statistically significant. Healthcare utilization and changes in anxiety were similar between the groups. More patients required additional ECGs or cardiac monitors in the control group (27.1%) compared to the KM/KP group (5.9%) ( P = .004)., Conclusions: Smartphone ECG with a cloud-based platform can be incorporated into the care of post-AF ablation patients without increasing anxiety and with less need for additional traditional monitors., (© 2021 Heart Rhythm Society.)

Transcatheter aortic valve replacement (TAVR) is a safe and feasible alternative to surgery in patients with symptomatic severe aortic stenosis regardless of the surgical risk. Conduction abnormalities requiring permanent pacemaker (PPM) implantation remain a common finding after TAVR due to the close proximity of the atrioventricular conduction system to the aortic root. High-grade atrioventricular block and new onset left bundle branch block (LBBB) are the most commonly reported conduction abnormalities after TAVR. The overall rate of PPM implantation after TAVR varies and is related to pre-procedural and intraprocedural factors. The available literature regarding the impact of conduction abnormalities and PPM requirement on morbidity and mortality is still conflicting. Pre-procedural conduction abnormalities such as right bundle branch block and LBBB have been linked with increased PPM implantation and mortality after TAVR. When screening patients for TAVR, heart teams should be aware of various anatomical and pathophysiological conditions that make patients more susceptible to increased risk of conduction abnormalities and PPM requirement after the procedure. This is particularly important as TAVR has been recently approved for patients with low surgical risk. The purpose of this review is to discuss the incidence, predictors, impact, and management of the various conduction abnormalities requiring PPM implantation in patients undergoing TAVR., Competing Interests: Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: This study characterized the microbiology of major cardiac implantable electronic device (CIED) infections that occurred during the WRAP-IT (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial) study., Background: The WRAP-IT study offers a unique opportunity for further understanding of the pathogens involved in major CIED infections in a prospective dataset, with implications for clinical practice and infection management., Methods: A total of 6,800 patients randomized 1:1 to receive an antibacterial envelope or not (control subjects) were included in this analysis. Patient characteristics, infection manifestation (pocket vs. systemic), and infection microbiology were evaluated through all follow-up (36 months). Data were analyzed using Cox proportional hazards regression., Results: A total of 3,371 patients received an envelope, and 3,429 patients were control subjects. Major CIED infection occurred in 32 patients who received an envelope and 51 control subjects (36-month Kaplan-Meier estimated event rate, 1.3% and 1.9%, respectively; p = 0.046). A 61% reduction in major pocket infection was observed within 12 months of the procedure in the envelope group (hazard ratio: 0.39, 95% confidence interval: 0.21 to 0.73; p = 0.003). Among 76 patients with major infections who had a sample taken, causative pathogens were identified in 47 patients. Staphylococcus species were the predominate pathogen (n = 31) and envelope use resulted in a 76% reduction in Staphylococcus-related pocket infections (n = 4 vs. 17; p = 0.010). Envelope use was not associated with delayed onset of pocket infections and did not affect the presentation of infections., Conclusions: Antibacterial envelope use resulted in a significant reduction of major CIED pocket infections and was particularly effective against Staphylococcus species, the predominant cause of pocket infections. (Worldwide Randomized Antibiotic Envelope Infection Prevention Trial [WRAP-IT]; NCT02277990)., Competing Interests: Author Disclosures This work was supported by Medtronic, Inc. Dr. Sohail has received honoraria/consultant fees from Medtronic and Aziyo Biologics, outside the submitted work. Dr. Corey has received honoraria/consultant fees from Medtronic, Arsanis, Basilea, Bayer, Contrafect, Melinta, Motif, Paratek, Pfizer, Quintiles, Tetraphase, The Medicines Company, Theravance, Bio2 Medical, Cempra, Meiji Seika Pharm Co., Novella, Regeneron, and SC Pharma. Dr. Wilkoff has received honoraria/consultant fees from Medtronic, Abbott, and Philips, outside the submitted work. Dr. Poole has received honoraria/consultant fees from Medtronic, Boston Scientific, Kestra, and EBR Solutions, outside the submitted work. Dr. Mittal has received honoraria/consultant fees from Medtronic, Abbott, and Boston Scientific, outside the submitted work. Dr. Kennergren has received honoraria/consultant fees from Medtronic, outside the submitted work. Dr. Greenspon has received honoraria, consultant fees, and a research grant from Medtronic; and has received honoraria from Boston Scientific, outside the submitted work. Dr. Tarakji has received honoraria/consultant fees from Medtronic and AliveCor, outside the submitted work. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 The Authors. Published by Elsevier Inc. All rights reserved.)

Objectives: This study compared rates of procedural success and complications between de novo cardiac resynchronization therapy (CRT) implantation versus upgrade, including characterization of technical challenges., Background: CRT upgrade is common, but data are limited on the incidence of procedural success and complications as compared to de novo implantation., Methods: All patients who underwent a transvenous CRT procedure at a single institution between 2013 and 2018 were reviewed for procedure outcome, 90-day complications, reasons for unsuccessful left ventricular lead delivery, and the presence of venous occlusive disease (VOD) that required a modified implantation technique., Results: Among 1,496 patients, 947 (63%) underwent de novo implantation and 549 (37%) underwent device upgrade. Patients who received a device upgrade were older (70 ± 12 years vs. 68 ± 13 years; p < 0.01), with a male predominance (75% vs. 66%; p < 0.01) and greater prevalence of comorbidities. There was no difference in the rate of procedural success between de novo and upgrade CRT procedures (97% vs. 96%; p = 0.28) or 90-day complications (5.1% vs. 4.6%; p = 0.70). VOD was present in 23% of patients who received a device upgrade and was more common among patients with a dual-chamber versus a single-chamber device (26% vs. 9%; p < 0.001). Patients with and without VOD had a similar composite outcome of procedural failure or complication (8.0% vs. 7.8%; p = 1.0)., Conclusions: Rates of procedural success and complications were no different between de novo CRT implantations and upgrades. VOD frequently increased procedural complexity in upgrades, but alternative management strategies resulted in similar outcomes. Routine venography before CRT upgrade may aid in procedural planning and execution of these strategies., Competing Interests: Author Disclosures Dr. Wilkoff has received honoraria/consultant fees from Medtronic, Abbott, and Philips Healthcare. Dr. Rickard has received honoraria/consultant fees from Abbott and Medtronic. Dr. Tarakji has received honoraria/consultant fees from Medtronic and AliveCor. Dr. Varma has received honoraria/consultant fees from St. Jude Medical, Boston Scientific, Biotronik, and Medtronic. Drs. Hussein and Wazni have received honoraria/consultant fees from Biosense Webster and Boston Scientific. Dr. Cantillon has received honoraria/consultant fees from Abbott and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

The field of cardiac electrophysiology has been on the cutting edge of advanced digital technologies for many years. More recently, medical device development through traditional clinical trials has been supplemented by direct to consumer products with advancement of wearables and health care apps. The rapid growth of innovation along with the mega-data generated has created challenges and opportunities. This review summarizes the regulatory landscape, applications to clinical practice, opportunities for virtual clinical trials, the use of artificial intelligence to streamline and interpret data, and integration into the electronic medical records and medical practice. Preparation of the new generation of physicians, guidance and promotion by professional societies, and advancement of research in the interpretation and application of big data and the impact of digital technologies on health outcomes will help to advance the adoption and the future of digital health care.

Background: Subclinical venous injuries are common during transvenous lead extraction (TLE), but their implications for future TLE are unclear. Little is known about whether a prior TLE adds risk or complexity to subsequent extraction procedures., Objective: The purpose of this study was to assess procedural profiles and outcomes of TLE based on whether patients had prior extraction procedures., Methods: All 3258 consecutive patients undergoing TLE at the Cleveland Clinic (1996-2012) were included. Procedural profiles and outcomes were determined., Results: Of 3258 TLEs, 198 had prior TLE. Median number of leads in place was 2 in both groups, but patients with prior TLE were more likely to have defibrillator leads (47% vs 41%; P = .08) and more likely to be pacemaker-dependent (32% vs 25%; P = .02). The age of oldest lead (median 2134 vs 1902 days; P = .4) and combined age of leads (median 2948 vs 2676 days; P = .6) were comparable. Procedures were longer in those with prior TLE (166 ± 79 minutes vs 149 ± 74 minutes; P = .004) with comparable fluoroscopy times (median 13 vs 11 minutes; P = .07), and successful extraction was more likely to require specialized tools (88% vs 81%; P = .006) with higher likelihood of rescue femoral workstation (12% vs 4%; P <.0001). Clinical success rates were comparable in those with prior TLE (99.5% vs 98.9%; P = .8) with similar major (3.0% vs 1.9%; P = .3) and minor (3.0% vs 3.7%; P = .8) complication rates., Conclusion: Extraction procedures were more challenging in patients with prior TLE compared to those without prior TLE but with excellent success and low complication rates., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Background: Virtual visits (VVs) are a modality for delivering health care services remotely through videoconferencing tools. Data about patient and physician experience in using VVs are limited., Objective: The purpose of this study was to assess patient and physician experience with the use of VVs in cardiac electrophysiology., Methods: We performed a prospective survey of cardiac electrophysiology patients and physicians who participated in an outpatient VV from December 2018 to July 2019., Results: One-hundred consecutive VVs were included. Sixty-four patients elected to complete a survey. Patients rated their experience as either excellent/very good in scheduling a VV (87%), seeing their physician of choice (100%), transmitting arrhythmia data (88%), rating their physician's ability to communicate (98%), asking all questions (98%), rating the level of care received (98%), paying for the cost of a VV (67%), and rating their overall level of satisfaction (98%). Thirty-eight of 64 patients (59.4%) preferred a VV for their next visit, 12 of 64 (18.8%) preferred an in-office visit, 13 of 64 (20.3%) responded that their decision for a virtual or office visit depended on indication, and 1 of 64 (1.6%) had no preference. A total of 14 cardiac electrophysiologists participated in 100 VVs. Nine visits were not included due to technical difficulty. Physician responses to survey questions were rated as excellent/very good in the ability to communicate (92%), accessing monitoring data (95%), and overall level of satisfaction (98%)., Conclusion: In our small study population, most patients and physicians prefer VVs. Convenience, cost, and reason for follow-up were important determinants that affected both patient and physician preference., (Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Objectives: The aims of this study were to assess outcomes of pulmonary vein isolation (PVI) performed on athletes at a tertiary care center and to characterize its efficacy and physiological effects., Background: The incidence of atrial fibrillation (AF) is increased in highly trained athletes and poses unique management challenges., Methods: Athletes were identified through a database of patients undergoing PVI from January 2000 through October 2015. Outcomes of AF ablation were defined in accordance with published guidelines. Available electrocardiographic, echocardiographic, and exercise treadmill testing data were also analyzed., Results: The study population included 144 athletes (93% men; mean age 50.4 ± 8.6 years; 97 paroxysmal, 38 persistent, and 9 long-standing persistent) with median follow-up of 3 years. Single-procedure freedom from arrhythmia was 75%, 68%, and 33% at 1 year for paroxysmal, persistent, and long-standing persistent AF, respectively. Multiple-procedure freedom from arrhythmia off antiarrhythmic drugs was 86%, 76%, and 56% in respective groups at the end of follow-up (mean 1.4 ± 0.7 ablations per athlete). Compared with a matched cohort of nonathletes who underwent PVI, there was no difference in arrhythmia recurrence (log-rank p = 0.23). Excluding long-standing persistent AF, longer diagnosis-to-ablation time was the only variable in Cox proportional hazards analyses associated with arrhythmia recurrence (adjusted heart rate per log increase: 1.92; 95% confidence interval: 1.40 to 2.73; p < 0.0001), and PVI within 2 years of diagnosis was notably associated with successful outcomes (log-rank p = 0.002). Sinus rate increased following the index ablation (mean 54 beats/min vs. 64 beats/min at >1 year; p < 0.0001), but maximum metabolic equivalents on exercise treadmill testing were unchanged (13.1 ± 1.2 vs. 12.7 ± 1.4; p = 0.44)., Conclusions: PVI is an effective therapy in athletes with paroxysmal and persistent AF, and arrhythmia recurrence was no different from that among matched nonathletes. Early ablation was associated with improved success rates. Sustained cardioautonomic effects were observed following ablation, but exercise capacity was preserved., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: In the WRAP-IT trial (Worldwide Randomized Antibiotic Envelope Infection Prevention), adjunctive use of an absorbable antibacterial envelope resulted in a 40% reduction of major cardiac implantable electronic device infection without increased risk of complication in 6983 patients undergoing cardiac implantable electronic device revision, replacement, upgrade, or initial cardiac resynchronization therapy defibrillator implant. There is limited information on the cost-effectiveness of this strategy. As a prespecified objective, we evaluated antibacterial envelope cost-effectiveness compared with standard-of-care infection prevention strategies in the US healthcare system., Methods: A decision tree model was used to compare costs and outcomes of antibacterial envelope (TYRX) use adjunctive to standard-of-care infection prevention versus standard-of-care alone over a lifelong time horizon. The analysis was performed from an integrated payer-provider network perspective. Infection rates, antibacterial envelope effectiveness, infection treatment costs and patterns, infection-related mortality, and utility estimates were obtained from the WRAP-IT trial. Life expectancy and long-term costs associated with device replacement, follow-up, and healthcare utilization were sourced from the literature. Costs and quality-adjusted life years were discounted at 3%. An upper willingness-to-pay threshold of $150 000 per quality-adjusted life year was used to determine cost-effectiveness, in alignment with the American College of Cardiology/American Heart Association practice guidelines and as supported by the World Health Organization and contemporary literature., Results: The base case incremental cost-effectiveness ratio of the antibacterial envelope compared with standard-of-care was $112 603/quality-adjusted life year. The incremental cost-effectiveness ratio remained lower than the willingness-to-pay threshold in 74% of iterations in the probabilistic sensitivity analysis and was most sensitive to the following model inputs: infection-related mortality, life expectancy, and infection cost., Conclusions: The absorbable antibacterial envelope was associated with a cost-effectiveness ratio below contemporary benchmarks in the WRAP-IT patient population, suggesting that the envelope provides value for the US healthcare system by reducing the incidence of cardiac implantable electronic device infection. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02277990.

Background: Many centers continue to routinely perform transesophageal echocardiograms before atrial fibrillation (AF) ablation procedures in patients treated with direct oral anticoagulants (DOACs). One study suggested that the procedures could be done without transesophageal echocardiogram but used intracardiac echocardiography imaging of the appendage from the right ventricular outflow. This study aimed to assess the safety of ablation for AF without transesophageal echocardiogram screening or intracardiac echocardiography imaging of the appendage in DOAC compliant patients., Methods: All patients undergoing AF ablation at the Cleveland Clinic (2011-2018) were enrolled in a prospectively maintained data registry. All consecutive patients presenting with AF or atrial flutter on DOAC were included. Periprocedural thromboembolic complications were assessed., Results: A total of 900 patients were included. Their median CHA 2 DS 2 -VASc score was 2 (interquartile range 1-3). All were on DOACs (333 rivaroxaban, 285 dabigatran, 281 apixaban, and 1 edoxaban). Thromboembolic complications occurred in 4 patients (0.3%): 2 ischemic strokes, 1 transient ischemic attack without residual deficit, and 1 splenic infarct; all with no further complications. Bleeding complications occurred in 5 patients (0.4%): 2 pericardial effusions (1 intraoperative, 1 after 30 days, both drained), 3 groin hematomas (1 of them due to needing heparin for venous thrombosis, none required interventions). No patients required emergent surgeries., Conclusions: In DOAC compliant patients who present for ablation in AF/atrial flutter, the procedures could be performed without transesophageal echocardiogram screening or intracardiac echocardiography imaging of the appendage; with low risk of complications.

Artificial intelligence (AI) and machine learning (ML) in medicine are currently areas of intense exploration, showing potential to automate human tasks and even perform tasks beyond human capabilities. Literacy and understanding of AI/ML methods are becoming increasingly important to researchers and clinicians. The first objective of this review is to provide the novice reader with literacy of AI/ML methods and provide a foundation for how one might conduct an ML study. We provide a technical overview of some of the most commonly used terms, techniques, and challenges in AI/ML studies, with reference to recent studies in cardiac electrophysiology to illustrate key points. The second objective of this review is to use examples from recent literature to discuss how AI and ML are changing clinical practice and research in cardiac electrophysiology, with emphasis on disease detection and diagnosis, prediction of patient outcomes, and novel characterization of disease. The final objective is to highlight important considerations and challenges for appropriate validation, adoption, and deployment of AI technologies into clinical practice.

Background: Many digital health technologies capable of atrial fibrillation (AF) detection are directly available to patients. However, adaptation into clinical practice by heart rhythm healthcare practitioners (HCPs) is unclear., Objective: To examine HCP perspectives on use of commercial technologies for AF detection and management., Methods: We created an electronic survey for HCPs assessing practice demographics and perspectives on digital devices for AF detection and management. The survey was distributed electronically to all members of 3 heart rhythm professional societies., Results: We received 1601 responses out of 73,563 e-mails sent, with 43.6% from cardiac electrophysiologists, 12.8% from fellows, and 11.6% from advanced practice practitioners. Most respondents (62.3%) reported having recommended patient use of a digital device for AF detection. Those who did not had concerns about their accuracy (29.6%), clinical utility of results (22.8%), and integration into electronic health records (19.8%). Results from a 30-second single-lead electrocardiogram were sufficient for 42.7% of HCPs to recommend oral anticoagulation for patients at high risk for stroke. Respondents wanted more data comparing the accuracy of digital devices to conventional devices for AF monitoring (64.9%). A quarter (27.3%) of HCPs had no reservations recommending digital devices for AF detection, and most (53.4%) wanted guidelines from their professional societies providing guidance on their optimal use., Conclusion: Many HCPs have already integrated digital devices into their clinical practice. However, HCPs reported facing challenges when using digital technologies for AF detection, and professional society recommendations on their use are needed., (© 2020 The Authors.)

Background: Dofetilide is one of the only anti-arrhythmic agents approved for atrial fibrillation (AF) in patients with reduced left ventricular ejection fraction (LVEF). However, postapproval data and safety outcomes are limited. In this study, we assessed the incidence and predictors of LVEF improvement, safety, and outcomes in patients with AF with LVEF ≤35% without prior implantable cardioverter defibrillator, cardiac resynchronization therapy, or AF ablation., Methods: An analysis of 168 consecutive patients from 2007 to 2016 was performed. Incidences of adverse events, drug continuation, implantable cardioverter defibrillator and cardiac resynchronization therapy implantation, LVEF improvement (>35%) and recovery (≥50%), AF recurrence, and AF ablation were determined. Multivariable regression analysis to identify predictors of LVEF improvement/recovery was performed., Results: The mean age was 64±12 years. Dofetilide was discontinued before hospital discharge in 46 (27%) because of QT prolongation (14%), torsades de pointe or polymorphic ventricular tachycardia/fibrillation (6% [sustained 3%, nonsustained 3%]), ineffectiveness (5%), or other causes (3%). At 1 year, 43% remained on dofetilide. Freedom from AF was 42% at 1 year, and 40% underwent future AF ablation. LVEF recovered (≥50%) in 45% and improved to >35% in 73%. Predictors of LVEF improvement included presence of AF during echocardiogram (odds ratio, 4.22 [95% CI, 1.71-10.4], P =0.002), coronary artery disease (odds ratio, 0.35 [95% CI, 0.16-0.79], P =0.01), left atrial diameter (odds ratio, 0.52 per 1 cm increase [95% CI, 0.30-0.90], P =0.01), and LVEF (odds ratio, per 1% increase, 1.09 [95% CI, 1.02-1.16], P =0.006). The C statistic was 0.78., Conclusions: In patients with LVEF ≤35%, who are potential implantable cardioverter defibrillator candidates, treated with dofetilide as an initial anti-arrhythmic strategy for AF, drug discontinuation rates were high, and many underwent future AF ablation. However, most patients had improvement in LVEF, obviating the need for primary prevention implantable cardioverter defibrillator.